Bristol Myers reported that its late-stage ALOFT-IPF trial of the oral drug admilparant met the primary endpoint at the 60 mg twice-daily dose in patients with Idiopathic Pulmonary Fibrosis.
- The higher 120 mg twice-daily dose slowed the decline in lung function but did not reach statistical significance.
- The company intends to complete a full review of the data and engage health authorities about next steps toward possible regulatory filings.
- Separately, the company said an interim analysis of the ACTION-1 trial studying RYZ101 in patients with gastroenteropancreatic neuroendocrine tumors met its main goal.
Bristol Myers Squibb (BMY) shares fell roughly 3% in midday trading on Monday, reversing opening gains, after the company reported mixed results from a late-stage trial in scarring lung disease — the study succeeded only at the lower dose tested while the higher dose fell short of statistical significance.
The company also announced positive results from its late-stage trial in a rare cancer.
Bristol Myers’ Lung-Disease Results Come With A Caveat
Bristol Myers reported that its late-stage ALOFT-IPF trial of the oral drug admilparant met the primary endpoint at the 60 mg twice-daily dose in patients with Idiopathic Pulmonary Fibrosis (IPF).
Patients receiving that dose showed a statistically significant improvement versus placebo in the absolute change in forced vital capacity—a standard measure of lung function—at 52 weeks. The higher 120 mg twice-daily dose slowed the decline in lung function but did not reach statistical significance. The company noted that both doses were generally well tolerated, with rates of discontinuation due to side effects that were low and similar to placebo.
Executives called the overall findings supportive of admilparant as a potential first-in-class approach targeting a specific biological pathway in idiopathic pulmonary fibrosis, a progressive disease that scars the lungs and leaves patients with limited effective options.
The company intends to complete a full review of the data and engage health authorities about next steps toward possible regulatory filings. Detailed results are planned for a future medical meeting. A related late-stage study in a broader form of progressive lung fibrosis is expected to report results in early 2027.
Cancer Therapy Shows Stronger Signal
Separately, the company said an interim analysis of the ACTION-1 trial met its main goal.
The study tested RYZ101, an experimental radiopharmaceutical therapy developed by its RayzeBio unit, in patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs) whose disease had progressed after earlier lutetium-based treatment.
RYZ101 produced a statistically significant and clinically meaningful improvement in the time patients lived without their cancer worsening, compared with standard options such as certain hormonal agents or other approved drugs. Safety findings matched what was previously known about the therapy.
Company executives described the outcome as an important milestone for patients with few remaining options after prior therapy and said they plan to discuss the data with regulators. The drug already carries orphan-drug designation for this rare disease. Detailed findings are expected at a future medical conference, and the trial will continue to track overall survival.
How Did BMY Retail Traders React?
On Stocktwits, retail sentiment around BMY stock stayed within ‘bearish’ territory over the past 24 hours, while message volume stayed at ‘high’ levels.
BMY stock has gained 6% year-to-date.
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